RIFL (Rigid and Flexing Laryngoscope) vs. Fiberoptic Bronchoscope

RIFL (Rigid and Flexing Laryngoscope) vs. Fiberoptic Bronchoscope: A Comparison of the Ease of Use During Intubation on Difficult Airways

We will conduct a randomized trial comparing the success rate and time to intubation using the RIFL vs. the fiberoptic bronchoscope, as the latter is commonly held to be the gold standard of difficult airway devices. Specifically, we wish to compare the of intubation between the two devices in patients with potentially difficult airways as defined by an oropharyngeal class 3-4, BMI greater than 35, or in patients with a history of difficult intubation using direct laryngoscopy.

Study Overview

• Status: Completed
• Conditions: Intubation; Difficult
• Intervention / Treatment: Device: RIFL (Rigid and Flexing Laryngoscope); Device: Fiberoptic Bronchoscope

Detailed Description

Patients who require general anesthesia with endotracheal intubation will be identified the night prior to their surgery based upon the examination documented in their preoperative history and physical. If their body mass index achieves a calculated score of 35 or greater or they have an oropharyngeal class 4 airway then they will qualify to participate.

After written informed consent is obtained, The intubation method would be randomized as one of two groups: intubation via use of the fiberoptic bronchoscope or the RIFL. The intubation attempt will be terminated if the SpO2 <90, HR<50, there is traumatic injury, or time > 100sec. If terminated, the patient will be mask ventilated and the attending anesthesiologist would determine the subsequent technique that will be used for airway management.

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Patients with known or suspected difficult airways defined as:

• patients with an oropharyngeal score of 3 or 4
• patients whose body mass index calculates greater to or equal to 35

Exclusion Criteria:

• Patients who necessitate an awake fiberoptic intubation or a rapid sequence intubation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: RIFL (Rigid and Flexing Laryngoscope); Patients in the RIFL group will undergo bronchoscopy using the Rigid and Flexing Laryngoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.	Device: RIFL (Rigid and Flexing Laryngoscope); Patients in the RIFL group will undergo bronchoscopy using the Rigid and Flexing Laryngoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.; Other Names: Video RIFL RIgid Flexible Laryngoscope; AI Medical Devices, Inc
Other: Fiberoptic Bronchoscope; Patients in the control group will undergo bronchoscopy using the flexible fiberoptic bronchoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.	Device: Fiberoptic Bronchoscope; Patients in the control group will undergo bronchoscopy using the flexible fiberoptic bronchoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time Until Proper Endotracheal Tube Placement	Time (in seconds) from first placement of the intubating scope in the oral cavity until proper endotracheal tube placement is confirmed by the presence of End Tidal Co2 (etCO2). Time to successful intubation was defined as the period from when the tip of the RIFL or FOB passed the incisors until withdrawal past that same point after successful intubation.	usually <100 seconds

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Successful Intubation	Successful intubation defined as confirming tube placement by the presence of etCO2;	<100 seconds
Number of Attempts Performed During Airway Management		<100 seconds
Grade of Glottic View	According to McCormack and Lehane	<100 seconds
Assistance Maneuvers, if Any, Provided by the Attending Anesthesiologist	Number of patients that required Assistance Maneuvers provided by the attending anesthesiologist such as jaw lift, tongue protrusion, laryngeal pressure, etc	<100 seconds
Lowest Pulse Oximetry Saturation Value Reading During Intubation	Lowest pulse oximetry saturation value reading collected from any participant during intubation	<100 seconds
Alternate Device Used		<100 seconds

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oropharyngeal Injuries	Number of patients with any notation of any trauma to lips, teeth, soft tissue, etc.	24 hours

Collaborators and Investigators

• Sponsor: Vanderbilt University
• Investigators: Principal Investigator: Bret Alvis, M.D., Vanderbilt University Medical Center

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: October 16, 2013
• First Submitted That Met QC Criteria: October 16, 2013
• First Posted (Estimate): October 18, 2013

Study Record Updates

• Last Update Posted (Estimate): January 5, 2017
• Last Update Submitted That Met QC Criteria: November 5, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 121408

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED